Regulatory Affairs Representative I

Process Engineer(Functional Litho & Acoustic Litho)

Engineer, Staff/Manager (Wet Etch / Electroplating)

QC Officer

Chemist Data Reviewer

Quality Assurance Associate

QC Chemist I

Responsibilities:&nbsp;&nbsp; <ul><li>Assists in the planning, development, maintenance, and implementation of the SDS authoring process.</li><li>Partners across all areas of expertise within the PSRA organization to monitor, promote, and deliver high quality, and fully compliant SDSs.</li><li>Identifies key measures to assist in driving continuous improvements and adherence to applicable regulatory requirements.</li><li>Actively fosters an organizational culture that is based on collaboration, partnership, innovation, customer service, driving change, and teamwork.</li><li>SDS and label data maintenance for new and existing products, intermediates and experimental products. Position works under direct supervision as needed.</li><li>Maintain regulatory and compositional information from raw materials suppliers and our businesses.</li><li>Manage our translation process with a 3rd party vendor.</li><li>Enter and maintain hazard assessment and regulatory data into product compliance support and MSDS authoring systems.</li><li>Provide internal and external customer support related to hazard communication including SDS distribution.</li><li>Actively participate in projects to continue to maintain compliance with global hazard communication regulations and related regulatory requirements.</li><li>Use product compliance tools to retrieve/query production models, specifications, recipes, labeling information, global database searches.</li><li>Support Product Stewardship and Regulatory Affairs activities.</li><li>Assist in special assignments and accepting new responsibilities as needed. External Use</li><li>Contribute to group projects by offering proposed solutions to problems and methods to accomplish the goals of the Product Stewardship and Regulatory Affairs Group.</li></ul> Requirements: Basic Qualifications:&nbsp; <ul><li>Associate degree in chemistry, Biological Sciences, Toxicology or HSE related field or equivalent experience in these fields.</li><li>Zero to two years of relevant experience.</li><li>Knowledge of MS excel, spreadsheet software, SAP like tools or similar Applications.</li></ul> Preferred Qualifications:&nbsp; <ul><li>Ability to multi-task and adapt to changing work priorities in a dynamic environment.</li><li>Strong interpersonal skills required to facilitate team building and partnering with colleagues and peers.</li><li>Ability to focus on details, work autonomously and lead projects.</li><li>SAP EHS module experience a plus.</li><li>Results driven with excellent communication skills.</li><li>Ability to handle multiple tasks/priorities and deal with ambiguity to meet specified deadlines.</li><li>Good analytical, problem solving and organizational skills.</li><li>Self-motivated, detail-oriented and comfortable working in a team environment.</li><li>Experience with innovative methodology for capturing and identifying metrics of key performance indicators.&nbsp;&nbsp;</li></ul>

Responsibilities: <ul><li>Drive/contribute in cost reduction, weed out unwarranted expenses/wastages, find alternative sources and improve processes with innovative solutions to raise efficiency.</li><li>Drive/contribute in quality investigations and continuous improvement programs to resolve chronic process and quality issues, and institute permanent resolutions to assure product quality and enhance process robustness.</li><li>Enforce on line controls and execution to conform to work instructions and procedures.&nbsp;</li><li>Apply hands-on and with deep involvement at work.</li><li>Monitor and analyse SPC charts and drive process control improvements.</li><li>Effective and timely disposition of on hold lots.</li><li>Regular reviews of OCAP, FMEA and Control Plans.</li><li>Ensure timely update of procedures and effective implementations.</li><li>Guide and train technicians in processes and problem solving and analysis to build up their technical competencies and achieve self-sustenance.</li><li>Take accountability of work and possesses strong sense of responsibility and team work.</li><li>Ensure non-conformance is dealt with in a proper and effective manner.</li><li>Establish, review and perform regular update of FMEA, OCAP, Process control, Risk Assessment and SIPOC on all critical processes to ensure a robust process.</li><li>Compliance with CSR, EHS, QM, ESD, 5S standard and cleanroom protocol.</li></ul> Requirements: <ul><li>Minimum Bachelor’s degree in Physics / Chemistry / Material Science/ Mechanical / Electronic or Electrical Engineering or equivalent.</li><li>Knowledge on semiconductor process technology.</li><li>Possess strong technical competencies in his field of study.</li><li>Good knowledge of statistical and quality tools.</li><li>Able to work under pressure and with strong commitment at work.</li><li>Experience with software applications such as MS Power Point, Excel and Word.</li><li>Experience with Lithography tools (Optional)</li></ul>

Responsibilities: <ul><li>Lead and manage a wafer fab manufacturing engineering module specializing in Wet Etch and Electroplating processes</li><li>Manage and develop a team of engineers and technicians in a high volume manufacturing environment</li><li>Drive excellence in output, quality, cost, equipment uptime, and safety</li><li>Ensure robust process control, stability, and integration across wet etch and plating operations</li><li>Lead root cause investigations for process, quality, and equipment issues and drive permanent corrective actions</li><li>Drive yield improvement, scrap reduction, and defect reduction through data driven analysis</li><li>Ensure high equipment availability and reliability, particularly for wet benches and plating tools</li><li>Apply and sustain SPC and statistical analysis tools to monitor and improve process performance</li><li>Actively contribute to continuous improvement programs to resolve chronic manufacturing or quality issues</li><li>Work closely with cross functional teams including Process Integration, Equipment, Quality, and Manufacturing</li><li>Provide technical and operational leadership during crisis situations impacting fab operations</li><li>Ensure strict compliance with EHS requirements, quality systems, cleanroom discipline, and wafer fab protocols</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering, Chemistry, Materials Science, Physics, or related discipline</li><li>Minimum 10 years of relevant experience in semiconductor wafer fabrication</li><li>Strong hands on technical expertise in Wet Etch, Electroplating, and related wet processes</li><li>Prior experience in high volume semiconductor manufacturing within an MNC environment</li><li>Strong understanding of:</li><li>Process integration</li><li>Statistical Process Control (SPC)</li><li>Yield improvement and scrap reduction methodologies</li><li>Equipment maintenance strategies for wet benches and plating tools</li><li>Proven people management experience, including coaching, talent development, succession planning, and manpower deployment</li><li>Demonstrated ability to lead root cause analysis and corrective action implementation</li><li>Strong sense of ownership with the ability to work effectively under pressure</li><li>Hands on leadership style with strong problem solving and decision making capabilities</li><li>Excellent communication and cross functional collaboration skills</li><li>Familiarity with statistical analysis tools, Excel, PowerPoint, and Word</li><li>Strong commitment to Environmental Health &amp; Safety (EHS), quality systems, and fab compliance</li></ul>

Role Description: <ul><li>Quality Control (QC) Officer with hands-on experience in analytical testing and laboratory operations within API, pharmaceutical, or chemical manufacturing industries.</li><li>The candidate should have strong exposure to HPLC and other analytical instruments along with knowledge of GMP/GLP documentation and quality systems.</li></ul> Responsibilities: <ul><li>Perform analysis of raw materials, in-process samples, and finished products as per specifications and SOPs.</li><li>Handle and operate analytical instruments such as: o	High-Performance Liquid Chromatography (HPLC) o	GC o	UV Spectrophotometer o	FTIR o	Karl Fischer</li><li>Conduct wet chemical analysis, titration, LOD, moisture analysis, and related QC activities.</li><li>Prepare mobile phase, standard solutions, reagents, and test samples for analysis.</li><li>Perform calibration and routine maintenance of laboratory instruments.</li><li>Maintain laboratory records, logbooks, COA documentation, and reports as per GMP/GLP guidelines.</li><li>Follow SOPs, safety standards, and quality compliance procedures.</li><li>Support audit activities and maintain data integrity.</li><li>Coordinate with QA and Production teams for quality-related activities.</li></ul> Requirements: <ul><li>Strong hands-on experience in HPLC analysis (Mandatory)</li><li>Knowledge of GC, UV, FTIR, and wet chemistry.</li><li>Understanding of GMP, GLP, SOPs, and documentation practices</li><li>Good analytical and troubleshooting skills.</li><li>Ability to work in rotational shifts and plant environment Preferred Candidate Profile</li><li>Experience in API / Pharmaceutical / Chemical manufacturing industry</li><li>Good exposure to QC laboratory operations</li><li>Strong attention to detail and documentation accuracy</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

Responsibilities:Primary responsibilities of this role include the following:With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.Support Drug Product Recall/Field alert management.Assist with review of Quality Agreements.For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.With supervision, review deviations/investigations related to the company's frontend products.Assist with SOP management for the company’s US corporate office.Support with quality matters for disposition of product returns.Assist during FDA inspections and local regulatory inspections at the company’s US corporate office.Requirements:Excellent verbal and written communication skills are necessary.With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.Motivated, results driven with attention to detail, accuracy and clarity.Qualifications: BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.Recent graduates will be considered for this role. 

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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7 chemistry Jobs found

Regulatory Affairs Representative I

Process Engineer(Functional Litho & Acoustic Litho)

Engineer, Staff/Manager (Wet Etch / Electroplating)

QC Officer

Chemist Data Reviewer

Quality Assurance Associate

QC Chemist I

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7 chemistry Jobs found

Regulatory Affairs Representative I

Process Engineer(Functional Litho & Acoustic Litho)

Engineer, Staff/Manager (Wet Etch / Electroplating)

QC Officer

Chemist Data Reviewer

Quality Assurance Associate

QC Chemist I

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.